MTPr With Shockwave on Pain & Function of SHS in Stroke

• Sponsor: October 6 University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04627636
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Background: shoulder-hand syndrome is considered a significant reason for the reduction of upper limb functions after stroke. Purpose: To investigate the influence of Myofascial Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper extremity in stroke patients with diabetic neuropathy.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Myofascial trigger points pressure (MTrP) release; Other: Shockwave therapy application; Other: conventional therapy	N/A

Detailed Description

Methods: two equal groups of thirty stroke patients, divided into, study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise programstudy group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Myofascial Trigger Points Release With Shockwave Therapy on Pain and Function of Shoulder Hand Syndrome in Stroke Patients With Diabetic Neuropathy
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group which treated with MTrPs release combined with shockwave therapy and conventional program	Other: Myofascial trigger points pressure (MTrP) release; Myofascial trigger points pressure (MTrP) release technique, the initial step was to recognize and find the trigger points (TP) , and The second step after TP palpation was the MTrP release technique, as follow, by one or both hands, the thumbs or four fingers of the therapist applied a maintained pressure, pushing internal toward the middle; Other: Shockwave therapy application; The JEST-2000 (JOEUN Medical, Dae-Jeon, South Korea) was used for the ESWT. The application of pressure pulses of ESWT was centered around the flexor muscles with hypertonia; Other: conventional therapy; Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone
Experimental: control group which treated with conventional physical therapy program	Other: conventional therapy; Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone

Outcome Measures

Primary Outcome Measures

1. - Complex Regional Pain Syndrome (CRPS) severity score [4 weeks]

   It is a quantitative index and valid instrument to score and monitor the severity of CRPS and SHS.

2. - Figure-of-Eight Method of Measuring Hand Size for hand swelling [4 weeks]

   The figure-of-eight technique utilizing tape measurement for hand size

3. - Visual analogue scale for pain (VAS-P) for pain assessment [4 weeks]

   The VAS for pain is a valid and reliable assessment of pain intensity, as a straight horizontal line of fixed length (10 cm) considered the simplest VAS.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• stroke from 4:8 months

• age ranging from 45:60 years

• All the patients were identified with SHS as diagnosed by the Diagnostic criteria for SHS post-stroke 18 and were in stage I of syndrome evolution

Exclusion Criteria:

• any other causes of shoulder pain in the hemiplegic side of the body

• a cognitive impairment

• structured joint deformity in the painful shoulder or hand

• other musculoskeletal disorders of UE.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lama S Mahmoud	Al Jīzah	Select State	Egypt

Sponsors and Collaborators

• October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University
• ClinicalTrials.gov Identifier: NCT04627636
• Other Study ID Numbers: No: P.T.REC/012/002459
• First Posted: Nov 13, 2020
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University: Stroke; Diabetic Neuropathy; Shoulder hand syndrome
• Additional relevant MeSH terms: Stroke; Diabetic Neuropathies

Study Results

No Results Posted as of Nov 13, 2020